FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KERALLOY NON-GAMMA 2 AMALGAM
K Number: K912992
·
Decision Nov 13, 1991
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
16
Review Days
128
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Basic Information
- Device Name
- KERALLOY NON-GAMMA 2 AMALGAM
- K Number
- K912992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wilde-USA, Inc.
- Date Received
- July 8, 1991
- Decision Date
- November 13, 1991
- Product Code
- EJJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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Other Clearances by Wilde-USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913582 | COMPATIT R | Jun 24, 1993 | Substantially Equivalent |
| K915653 | KERAMAIL | Apr 8, 1993 | Substantially Equivalent |
| K913581 | WILDE ADHESIVE BONDING SYSTEM | Feb 26, 1993 | Substantially Equivalent |
| K923472 | COMPACOLOR | Oct 13, 1992 | Substantially Equivalent |
| K920649 | COMPASEP | Jul 23, 1992 | Substantially Equivalent |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | Apr 21, 1992 | Substantially Equivalent |
| K915250 | WIL-PDS & WIL-PDI CASTING ALLOYS | Apr 21, 1992 | Substantially Equivalent |
| K912990 | CONVERBASE | Mar 25, 1992 | Substantially Equivalent |
| K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX | Mar 20, 1992 | Substantially Equivalent |
| K915654 | KERALLOY-D CAPS | Mar 2, 1992 | Substantially Equivalent |